US2002102721A1PendingUtilityA1

Antibodies against md2 protein

27
Priority: Jun 27, 1990Filed: Nov 30, 1998Published: Aug 1, 2002
Est. expiryJun 27, 2010(expired)· nominal 20-yr term from priority
Inventors:Arnold J. LevineCathy A. FinlayCarlos Cordon-Cardo
G01N 33/57595G01N 33/57575C07K 14/475C07K 14/4746C07K 14/82C07K 16/22C07K 16/32C12Q 1/6886G01N 2333/82Y10S436/813C12Q 2600/118C12Q 2600/136
27
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Claims

Abstract

The invention provides a method of diagnosing cancer by determining the expression level or gene amplification of p53 and dm2, whereby an elevated level of either p53 or dm2 or both p53 and dm2 indicates a cancer diagnosis. Furthermore, the invention provides a method of predicting the progress of cancer by determining the expression level or gene amplification of p53 and dm2, whereby an elevated level of either p53 or dm2 or both 53 and dm2 indicates a poor prognosis.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A method of diagnosing cancer by determining the level of p53 and dm2 in a biological sample, whereby an elevated level of either p53 or dm2 or both p53 and dm2 indicates a cancer diagnosis.  
     
     
         2 . A method of predicting the progress of cancer by determining the level of p53 and dm2 in a biological sample, whereby an elevated level of either p53 or dm2 or both p53 and dm2 indicates a poor prognosis.  
     
     
         3 . A method of classifying a biological sample into one of three groups, the method comprising determining whether the level of either p53 or dm2 in the sample is abnormally elevated, whereby the first group comprises no abnormal elevation of either the level of p53 or dm2, the second group comprises abnormal elevation of the level of p53 and no abnormal elevation of the level of dm2 or abnormal elevation of the level of dm2 and no abnormal elevation of the level of p53, and the third group comprises abnormal elevation of the level of both p53 and dm2.  
     
     
         4 . A method of assessing a subject's prognosis by obtaining a biological sample from the subject, classifying the sample's group using the method of  claim 3 , whereby, of the three groups, the third group indicates the worst prognosis.  
     
     
         5 . A method of assessing a subject's prognosis by obtaining a biological sample from the subject, determining the sample's group using the method of  claim 3 , whereby, of the three groups, the first group indicates the best prognosis.  
     
     
         6 . A method according to  claim 3 , wherein the level of dm2 gene amplification or expression is determined by using probes.  
     
     
         7 . A method according to  claim 6 , wherein the probes are antibodies.  
     
     
         8 . A method according to  claim 7 , wherein the antibodies are monoclonal.  
     
     
         9 . A method according to  claim 8 , wherein the antibodies are selected from the group consisting of claims  14 - 18 .  
     
     
         10 . A monoclonal antibody of  claim 27 ,  28 ,  29 ,  30  or  31  bound to a toxin.  
     
     
         11 . A method of treating a patient with a tumor by contacting the tumor with an antibody of  claim 10  under conditions such that the antibody binds to the tumor.  
     
     
         12 . A monoclonal antibody of  claim 27 ,  28 ,  29 ,  30  or  31  labeled with a detectable marker.  
     
     
         13 . A method for imaging tumors which comprises contacting the tumor to be imaged with an anti-dm2 antibody of  claim 12 , under conditions such that the antibody binds to the tumor and detecting the antibody bound thereto, thereby imaging the tumor.  
     
     
         14 . A method of detecting in a biological sample cancer cells or cells at risk of becoming cancerous or pre-cancerous, wherein the cells contain at least one normal p53 allele, the method comprising determining whether the level of dm2 in the biological sample is abnormally elevated in comparison with the level of dm2 expression, whereby an abnormally elevated level of dm2 in the biological sample indicates cancer cells or cells at risk of becoming cancerous or pre-cancerous.  
     
     
         15 . A method according to  claim 14 , wherein the elevated level is determined by immunohistochemical staining of the biological sample.  
     
     
         16 . A method according to  claim 14 , wherein the level of dm2 gene amplification or expression is determined by using probes.  
     
     
         17 . A method according to  claim 16 , wherein the probes are nucleic acid probes.  
     
     
         18 . A method according to  claim 16 , wherein the probes are antibodies.  
     
     
         19 . A method according to  claim 18 , wherein the antibodies are monoclonal.  
     
     
         20 . A p53/dm2 complex.  
     
     
         21 . A method according to  claim 19 , wherein the monoclonal antibody is produced by hybridoma 3G5, deposited under ATCC Accession No. HB 11182.  
     
     
         22 . A method according to  claim 19 , wherein the monoclonal antibody is produced by hybridoma 4B11, deposited under ATCC Accession No. HB 11183.  
     
     
         23 . A method according to  claim 19 , wherein the monoclonal antibody is produced by hybridoma 2A10, deposited under ATCC Accession No. HB 11184.  
     
     
         24 . A method according to  claim 19 , wherein the monoclonal antibody is produced by hybridoma 2A9, deposited under ATCC Accession No. HB 11185.  
     
     
         25 . A method according to  claim 19 , wherein the monoclonal antibody is produced by hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         26 . A method according to  claim 19 , wherein the monoclonal antibody recognizes the same epitope or epitopes as those recognized by a monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         27 . A method according to  claim 19 , wherein the monoclonal antibody competes with the same epitope or epitopes as those recognized by a monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         28 . A method according to  claim 27 , wherein the competing monoclonal antibody blocks between 50-100% of the epitope or epitopes recognized by the monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         29 . The monoclonal antibody produced by hybridoma 3G5, deposited under ATCC Accession No. HB 11182.  
     
     
         30 . The monoclonal antibody produced by hybridoma 4B11, deposited under ATCC Accession No. HB 11183.  
     
     
         31 . The monoclonal antibody produced by hybridoma 2A10, deposited under ATCC Accession No. HB 11184.  
     
     
         32 . The monoclonal antibody produced by hybridoma 2A9, deposited under ATCC Accession No. HB 11185.  
     
     
         33 . The monoclonal antibody produced by hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         34 . A monoclonal antibody that recognizes the same epitope or epitopes as those recognized by a monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         35 . A monoclonal antibody that competes with the same epitope or epitopes as those recognized by a monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         36 . A monoclonal antibody according to  claim 35  that blocks between 50-100% of the epitope or epitopes recognized by the monoclonal antibody produced by a hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         37 . A hybridoma selected from the group consisting of hybridoma 3G5, deposited under ATCC Accession No. HB 11182; hybridoma 4B11, deposited under ATCC Accession No. HB 11183; hybridoma 2A10, deposited under ATCC Accession No. HB 11184; hybridoma 2A9, deposited under ATCC Accession No. HB 11185; and hybridoma 4B2, deposited under ATCC Accession No. HB 11186.  
     
     
         38 . Any epitope recognized by a monoclonal antibody selected from the group of monoclonal antibodies of claims  29 - 33 .  
     
     
         39 . An epitope recognized by a monoclonal antibody of  claim 31 .  
     
     
         40 . A diagnostic kit comprising: 
 (a) a container comprising an anti-p53 antibody that recognizes a p53 protein; and    (b) a container comprising an anti-dm2 antibody that recognizes a dm2 protein.    
     
     
         41 . A diagnostic kit of claim  40 , wherein the antibodies are labeled.  
     
     
         42 . A diagnostic kit of claim  40 , further comprising: 
 (a) a labeled antibody that recognizes the anti-p53 antibody; and    (b) a labeled antibody that recognizes the anti-dm2 antibody.

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